Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
Last week, we reported on findings from the FLOW clinical trial which compared the safety and efficacy of once weekly injectable semaglutide 1.0 mg against placebo as an adjunct to standard of care on kidney outcomes in a cohort of 3533 individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).
The study
The FLOW trial was a randomized, double-blind, parallel-group, placebo-controlled, superiority trial launched in 2019. It was halted in early October 2023 after meeting prespecified criteria for early discontinuation based on efficacy.
The study’s primary endpoint combined 5 components measuring the progression of CKD and the risk of kidney and cardiovascular mortality:
onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline
onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2
initiation of chronic kidney replacement therapy (dialysis or kidney transplantation)
death from kidney disease
death from CV disease
Secondary outcomes pursued in FLOW included annual rate of change of eGFR, 3-point major adverse cardiovascular events (MACE), and all-cause death.
The findings
Among persons with T2D and CKD, semaglutide 1.0 mg reduced the risk of kidney disease progression and CV- and renal-related death by 24% compared with placebo. The safety and tolerability of semaglutide 1.0 mg in the FLOW study was consistent with previous studies of the 1 mg dose.
Authors' comment
“Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”
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